Asia Pacific Beauty Products Ltd

⚠️ Moderate Risk

FEI: 3005429034 • Kowloon, FN • HONG KONG

FEI

FEI Number

3005429034

📍

Location

Kowloon, FN

🇭🇰

Country

HONG KONG

🏢

Address

Rm403-5 4/F Hkpac Ctr 28 Hankow, , Kowloon, FN, Hong Kong

Moderate Risk

FDA Import Risk Assessment

32.2

LowModerateHighCritical

This firm has a moderate history of FDA import refusals. Some attention may be warranted.

Statistics

Total Refusals

Unique Violations

4/12/2005

Latest Refusal

2/25/2003

Earliest Refusal

Score Breakdown

Violation Severity

50.0×40%

Refusal Volume

31.3×30%

Recency

0.0×20%

Frequency

28.2×10%

How is this score calculated?

Proprietary Algorithm

40% Violation Severity — AI-assessed (1-10)
30% Refusal Volume — Logarithmic scale
20% Recency — Decays over 5 years
10% Frequency — Refusals per year

Violation Summary

1183×

NOT LISTED

It appears the drug or device is not included in a list required by Section 510(j), or a notice or other information respecting it was not provided as required by section 510(j) or 510(k).

3413×

REGISTERED

It appears the device is subject to listing under 510(j) and the initial distributor has not registered as required by 21 CFR 807.20 (a)(5).

5083×

NO 510(K)

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it is a post 1976 device for which a Section 510(k)application does not appear to have been determined substantially equivalent or otherwise filed.

Refusal History

Date	Product	Violations	Division
4/12/2005	95U19SUNLAMP PRODUCT (PRE-STANDARD) FOR NON-MEDICAL USE	118NOT LISTED 508NO 510(K)	San Francisco District Office (SAN-DO)
2/18/2005	95U19SUNLAMP PRODUCT (PRE-STANDARD) FOR NON-MEDICAL USE	118NOT LISTED 508NO 510(K)	San Francisco District Office (SAN-DO)
2/18/2005	89NHNLAMP, NON-HEATING, FOR ADJUNCTIVE USE IN PAIN THERAPY	118NOT LISTED 508NO 510(K)	San Francisco District Office (SAN-DO)
8/30/2004	89ISAMASSAGER, THERAPEUTIC, ELECTRIC	341REGISTERED	Los Angeles District Office (LOS-DO)
8/30/2004	80FQMBANDAGE, ELASTIC	341REGISTERED	Los Angeles District Office (LOS-DO)
2/25/2003	89ISAMASSAGER, THERAPEUTIC, ELECTRIC	341REGISTERED	Seattle District Office (SEA-DO)

Frequently Asked Questions

What is Asia Pacific Beauty Products Ltd's FDA import refusal history?

Asia Pacific Beauty Products Ltd (FEI: 3005429034) has 6 FDA import refusal record(s) in our database, spanning from 2/25/2003 to 4/12/2005.

What is an FEI number?

FEI stands for Firm Establishment Identifier. It's a unique number assigned by the FDA to identify establishments that manufacture, process, pack, or hold food, drugs, medical devices, or other FDA-regulated products. Asia Pacific Beauty Products Ltd's FEI number is 3005429034.

What types of violations has Asia Pacific Beauty Products Ltd received?

Asia Pacific Beauty Products Ltd has been cited for 3 different violation type(s). Common FDA violations include adulteration (unsafe or unsanitary products), misbranding (incorrect or misleading labels), and regulatory non-compliance.

Where does this information about Asia Pacific Beauty Products Ltd come from?

All FDA import refusal data for Asia Pacific Beauty Products Ltd is sourced from the official FDA Data Dashboard (datadashboard.fda.gov), a public government database maintained by the U.S. Food and Drug Administration.

Data sourced from the FDA Data Dashboard, a public database maintained by the U.S. Food and Drug Administration.